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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K203010
Device Name Platinum dRF Imaging System
Applicant
Apelem-DMS Group
Parc Scientifique Georges Besse 175 Alle Von Neumann
Nimes,  FR 30005
Applicant Contact Samuel Sancerni
Correspondent
MEDIcept, Inc.
200 Homer Ave
Ashland,  MA  01721
Correspondent Contact Scott Blood
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/01/2020
Decision Date 01/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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